CN108744026A - 即配型几丁多糖冻干粉 - Google Patents
即配型几丁多糖冻干粉 Download PDFInfo
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Abstract
本发明公开了即配型几丁多糖冻干粉，应用于围手术期的一种即配型医用止血防粘连、控制癌细胞转移生物材料，以羧甲基壳聚糖冻干粉为主要原料，注射用水为载体再配以调节渗透压物质氯化钠或甘氨酸为辅料，使用磷酸盐缓冲液调节PH配制成平衡盐溶液。在肿瘤外科手术方面，具有预防性的防止在肿瘤手术中散落在人体腔体内膜的肿瘤细胞引发的种植性转移。对人体无无毒性、刺激性、无致敏，具有良好的生物降解性，具有良好的止血、抗菌、防粘连、控制癌细胞种植性转移效果。
Description
技术领域
本发明涉及即配型几丁多糖冻干粉，应用于围手术期的一种即配型医用止血防粘连、控制癌细胞转移生物材料，属于生物药品或医疗器械敷料类。
背景技术
贯穿外科围手术期应用临床的用于止血、抗菌、防粘连生物材料。主要高分子化合物有：羧甲基纤维素、透明质酸钠、海藻酸盐敷料及壳聚糖类生物材料。但这些材料中唯一带有正电荷天然高分子化合物仅有壳聚糖。由于细菌等病原微生物、癌细胞、红细胞及血小板表面带有一定量负电荷，通过临床试验具有良好的止血、消炎、抗菌、控制癌细胞种植性转移良好及促进创面愈合和预防组织间粘连临床效果。
虽然壳聚糖目前已有部分产品应用于临床患者，但都是粗加工产品。真正达到符合人体生物安全性要求产品不多。主要困难在于原料易得但达到药用级注射级生物材料提取精制目前市场还是空白。羧甲基壳聚糖水溶液物理机化学性质不稳定，长期放置溶液降解丧失其生物学特性，如何解决不能长期保存问题是利用好壳聚糖生物学特性必须解决技术性问题。
发明内容
为了克服上述现有技术的不足，本发明提供了一种即配型几丁多糖冻干粉，属于外科围手术期具有止血、抗菌、防粘连的一种高分子生物材料；在肿瘤外科手术方面，具有预防性的防止在肿瘤手术中散落在人体腔体内膜的肿瘤细胞引发的种植性转移。另外，可以做到现配现用，使用方便保存期长，解决了羧甲基壳聚糖水溶液物理机化学性质不稳定，长期放置溶液降解丧失其生物学特性，解决不能长期保存问题。
本发明是通过如下技术方案实现的，即配型几丁多糖冻干粉，包括双室袋；所述双室袋分为固态室A和液态室B；
在固态室A和液态室B中各原料组份及其质量分数为：
固态室A：
羧甲基壳聚糖冻干粉 0.1%-10.0%；
液态室B：
氯化钠 0.1%-1.0%；
或甘氨酸 3.0%-5.0%；
磷酸盐缓冲液调节PH至4.5-7.5；
注射用水 余量。
作为本发明所述的即配型几丁多糖冻干粉的一种优化方案：所述双室袋中的固态室A和液态室B为并排排列，所述固态室A和液态室B连接处设置有虚焊连接部；所述双室袋上分别设有与固态室A连通的加固料口和出液口，以及与液态室B连通的加液体口。
作为本发明所述的即配型几丁多糖冻干粉的一种优化方案：所述双室袋的使用方法如下：
步骤1）通过加固料口和加液体口分别向固态室A和液态室B加入各原料组份及其用量；
步骤2）通过挤压使得固态室A和液态室B之间虚焊连接部连通，即可达到现配现用。
本发明有益技术效果：本产品对人体无无毒性、刺激性、无致敏，具有良好的生物降解性，重点解决肿瘤外科手术过程中散落癌细胞于腹腔等粘膜及组织引发种植性转移控制。
作用机制：
1.控制癌细胞种植性转移由于羧甲基壳聚糖分子表面带有正电荷，癌细胞表面带有负电荷，两者通过库仑的吸附作用，将癌细胞吸附于羧甲基壳聚糖表面，防止扩散，并抑制癌细胞的生长，干扰癌细胞的正常代谢，从而杀灭癌细胞。和本产品中的氯化钠盐水对癌细胞具有溶胀作用，从而破坏癌细胞，进而达到防止癌细胞在体腔内粘膜种植性转移。
2.止血作用：羧甲基壳聚糖分子中已脱去N-乙酰基、氨基上暴露的正电荷，能吸附血红细胞本身所具有的负电荷使其凝集，同时羧甲基壳聚糖的水溶胶体在人体局部伤口处，利用本身具有的线状纤维蛋白纵横交错，能有效的将血细胞网织期间，使形成了正常的纤维蛋白血凝块，在正电荷和线状纤维蛋白双重作用下起良好的止血效果。
3.抗菌作用：由于羧甲基壳聚糖分子中的正电荷作用，干扰了细菌细胞外壁的代谢，通过库仑吸附的作用将细菌粘连在一起，阻止扩散，并抵制了细菌生长，同时羧甲基壳聚糖溶液形成的高分子膜，阻止了营养物质向细菌内传输，在这双重作用下起到良好的抗菌效果。
4.促进伤口愈合作用：促进伤口愈合活性作用强弱在于葡萄胺的浓度高低，因为葡萄糖胺是羧甲基壳聚糖分子链上的主要成分，并且其止血、止痛、抗菌作用，这些作用对于伤口愈合都有积极意义。
5.防粘连作用：由于羧甲基壳聚糖具有止血和生物屏障作用，能促进上皮细胞和血管内皮细胞生长，能选择性抑制成纤维细胞生长，从而减少了胶原纤维来源，达到预防和减轻粘连的目的，在不影响正常组织愈合的情况下有效地防止组织粘连。
附图说明
图1是本发明中双室袋结构示意图；
图中：1-出液口；2-加固料口；3-加液体口；A-固态室；B-液态室。
具体实施方式
下面结合实例进一步详述本发明。
实施例1
即配型几丁多糖冻干粉，包括双室袋；所述双室袋分为固态室A和液态室B；
在固态室A和液态室B中各原料组份及其质量分数为：
固态室A：
羧甲基壳聚糖冻干粉 0.5%；
液态室B：
氯化钠 0.9%；
磷酸盐缓冲液调节PH至5.0；
注射用水 余量。
所述双室袋中的固态室A和液态室B为并排排列，所述固态室A和液态室B连接处设置有虚焊连接部；所述双室袋上分别设有与固态室A连通的加固料口2和出液口1，以及与液态室B连通的加液体口3。
所述双室袋的使用方法如下：
步骤1）通过加固料口2和加液体口3分别向固态室A和液态室B加入各原料组份及其用量；
步骤2）通过挤压使得固态室A和液态室B之间虚焊连接部连通，即可达到现配现用。
实施例2
即配型几丁多糖冻干粉，包括双室袋；所述双室袋分为固态室A和液态室B；
在固态室A和液态室B中各原料组份及其质量分数为：
固态室A：
羧甲基壳聚糖冻干粉 5.0%；
液态室B：
氯化钠 0.8%；
磷酸盐缓冲液调节PH至6.5；
注射用水 余量。
所述双室袋中的固态室A和液态室B为并排排列，所述固态室A和液态室B连接处设置有虚焊连接部；所述双室袋上分别设有与固态室A连通的加固料口2和出液口1，以及与液态室B连通的加液体口3。
所述双室袋的使用方法如下：
步骤1）通过加固料口2和加液体口3分别向固态室A和液态室B加入各原料组份及其用量；
步骤2）通过挤压使得固态室A和液态室B之间虚焊连接部连通，即可达到现配现用。
实施例3
即配型几丁多糖冻干粉，其特征在于：包括双室袋；所述双室袋分为固态室A和液态室B；
在固态室A和液态室B中各原料组份及其质量分数为：
固态室A：
羧甲基壳聚糖冻干粉 0.4%；
液态室B：
甘氨酸 3.5%；
磷酸盐缓冲液调节PH至7.0；
注射用水 余量。
所述双室袋中的固态室A和液态室B为并排排列，所述固态室A和液态室B连接处设置有虚焊连接部；所述双室袋上分别设有与固态室A连通的加固料口2和出液口1，以及与液态室B连通的加液体口3。
所述双室袋的使用方法如下：
步骤1）通过加固料口2和加液体口3分别向固态室A和液态室B加入各原料组份及其用量；
步骤2）通过挤压使得固态室A和液态室B之间虚焊连接部连通，即可达到现配现用。
Claims (3)
1.即配型几丁多糖冻干粉，其特征在于：
包括双室袋；所述双室袋分为固态室A和液态室B；
在固态室A和液态室B中各原料组份及其质量分数为：
固态室A：
羧甲基壳聚糖冻干粉 0.1%-10.0%；
液态室B：
氯化钠 0.1%-1.0%；
或甘氨酸 3.0%-5.0%；
磷酸盐缓冲液调节PH至4.5-7.5；
注射用水 余量。
2.根据权利要求1所述的即配型几丁多糖冻干粉，其特征在于：所述双室袋中的固态室A和液态室B为并排排列，所述固态室A和液态室B连接处设置有虚焊连接部；所述双室袋上分别设有与固态室A连通的加固料口（2）和出液口（1），以及与液态室B连通的加液体口（3）。
3.根据权利要求2所述的即配型几丁多糖冻干粉，其特征在于：所述双室袋的使用方法如下：
步骤1）通过加固料口（2）和加液体口（3）分别向固态室A和液态室B加入各原料组份及其用量；
步骤2）通过挤压使得固态室A和液态室B之间虚焊连接部连通，即可达到现配现用。
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